Abstract
Chronic Rhinosinusitis is characterized by inflammation of lining of nose and paranasal sinuses leading to nasal blockage/discharge, facial pressure/pain and loss of smell sensation, generally treated with medical therapy initially. Nasal saline irrigation is one of the treatment modalities commonly used to improve symptoms. The aim was to evaluate efficacy of adding normal saline nasal spray to standard treatment regimen of chronic rhinosinusitis. A randomized, controlled, single blinded study with 40 chronic rhinosinusitis patients. Study group was prescribed Normal Saline nasal spray (1 puff in each nostril, thrice daily) along with topical corticosteroids (Mometasone furoate nasal spray, 1 puff in each nostril, twice daily; 1 puff = 50 µg), and oral antibiotics (Amoxicillin + Clavulanic acid, 30 mg/kg, twice daily), and the control group was only prescribed topical corticosteroids and oral antibiotics. Patients were evaluated using Lund–Kennedy endoscopic scores and Sino-Nasal Outcome Test before and after treatment. There was a significant improvement in LKES, with pre-treatment and post-treatment scores for control group being 5.35 ± 2.43 vs 3.70 ± 1.95 respectively (p = 0.0116), whereas for test group, pre-treatment and post-treatment scores were 8.15 ± 2.62 vs 6.05 ± 2.04 respectively (p = 0.0037). Improvement in SNOT-22 scores were observed as well, with pre-treatment and post-treatment scores for control group being 38.90 ± 12.01 vs 25.70 ± 9.21 respectively (p = 0.0002), whereas for test group, pre-treatment and post-treatment scores were 49.85 ± 11.38 vs 31.55 ± 9.91 respectively (p < 0.0001). The study suggests that there is additional benefit in usage of normal saline in form of symptomatic relief as well as clinical improvement.
Keywords: Rhinosinusitis, Normal saline, Nasal irrigation, Lund-Kennedy endoscopic score, SNOT-22
Introduction
Chronic rhinosinusitis (CRS) is an inflammatory process of the mucosa of nasal cavity and paranasal sinuses. It is one of the most common chronic health problems affecting about 11% of the population globally [1]. Its impact on health and quality of life of the individual is constantly increasing both in developing and developed countries. However, the easily accessible and affordable intervention in early stages results in considerable improvement of symptoms.
The aim of medical treatment is to reduce inflammation, reduce bacterial load and optimize ciliary function by removing mucus [1]. Hence one of the approaches that is followed in conservative management includes a combination therapy with empirical antibiotics and intranasal corticosteroids, that aim at reducing microbial load and targeting mucosal inflammation, respectively. In order to optimize mucociliary clearance, a number of modalities have been tried like saline irrigation and use of muco-active agents.
Saline irrigation is useful in improvement of mucociliary clearance by the removal of mucus, infected crusts and pro-inflammatory agents. Isotonic saline and hypertonic saline are the most commonly used modalities for nasal irrigation. Although use of hypertonic saline has been shown to have better radiological improvement in comparison to isotonic saline, it causes more local adverse effects such as inflammation and rhinorrhea [1] and hence patient tolerance is less. Normal Saline can be thought of a superior option for the advantage of it having better fluid balance in addition to better nasal patency [2] and tolerability.
Intranasal Normal Saline is a commonly practiced post-operative therapy in secondary CRS. However, its role as a first line treatment modality in primary CRS has not been extensively studied. Very few recent studies [3–6], especially in India [4], have been performed that examine the effect of topical Normal Saline in conservative management of CRS. No recent studies have been done that evaluate the role of Normal Saline separately.
Methodology
A hospital based, randomized controlled study was conducted for a duration of 1 year. Forty cases of CRS attending Otorhinolaryngology OPD of tertiary care center from January 2021 to December 2021 were included in the study. Computer generated randomization was performed. Patients of the age group 18–65 years were included. Exclusion criteria comprised of patients with immunocompromised status, previous history of nasal surgery or radiotherapy to head and neck region, known cases of head and neck malignancy and cases of mucociliary disorders.
Patients’ details and history were obtained. Any other symptoms apart from nose complaints were noted. A thorough clinical examination was done for all patients with anterior and posterior rhinoscopy and Diagnostic Nasal Endoscopy (DNE). Pre-treatment Lund-Kennedy Endoscopic Score (LKES) as well as 22-item Sino-nasal Outcome Test (SNOT-22) were assessed and noted in the same proforma. After clinical diagnosis, using computer generated randomization, the subject was allocated to either the Study group or the Control group. The patients in study group were prescribed Normal Saline nasal spray (1 puff in each nostril, three times a day) in addition to standard treatment regimen of CRS comprising of topical corticosteroids (Mometasone furoate nasal spray, 1 puff in each nostril, two times a day; 1 puff = 50 µg), and oral antibiotics (Amoxicillin + Clavulanic acid, 30 mg/kg, two times a day), while the control group was only prescribed topical corticosteroids and oral antibiotics. Patients were re-assessed after 3 weeks of receiving treatment using post-treatment SNOT-22 score and DNE.
Lund-Kennedy endoscopy scoring system was used to compare pre-treatment and post-treatment endoscopy outcomes.
Statistical Analysis
Our study was focused on comparison of two groups. The mean and the standard deviation for the continuous quantitative variables were calculated. The Unpaired Student's t test and other appropriate statistical methods were used to compare the continuous variables between groups. Using the Student's Paired t test, two quantitative variables within a group were compared. Using the Chi-square test or Fisher’s exact test, the relationship between the result, clinical, and demographic factors was evaluated. Discrete variables were represented by median. Nonparametric tests were used for comparing discrete variables. For all tests, a value of p which was less than 5% (0.05) was considered significant. SPSS software was used for statistical analysis.
Results
As outlined in Fig. 1, for control group, mean Lund Kennedy Endoscopic Score before the treatment was 5.35 ± 2.43 whereas after the treatment score was 3.70 ± 1.95, with minimum score being 3, maximum score being 11 (p = 0.0116). For test group, mean Lund Kennedy Endoscopic Score before the treatment was 8.15 ± 2.62 whereas mean score after the treatment was 6.05 ± 2.04 (p = 0.0037). The intra-group comparison is listed in Table 1.
Fig. 1.
Graph comparing mean Lund-Kennedy Endoscopic Scores before and after treatment
Table 1.
Lund-Kennedy endoscopic scoring, intra-group comparison
| Before | After | p value | |||||||
|---|---|---|---|---|---|---|---|---|---|
| Mean | SD | Min | Max | Mean | SD | Min | Max | ||
| Control group | 5.35 | 2.43 | 3 | 11 | 3.70 | 1.95 | 2 | 8 | 0.0116 |
| Test group | 8.15 | 2.62 | 5 | 14 | 6.05 | 2.04 | 3 | 10 | 0.0037 |
As outlined in Fig. 2, for control group, mean SNOT-22 score before the treatment was 38.90 ± 12.01 whereas after the treatment score was 25.70 ± 9.21 (p = 0.0002). For test group, mean score before the treatment was 49.85 ± 11.38 whereas mean score after the treatment was 31.55 ± 9.91 (p < 0.0001). The intra-group comparison is listed in Table 2.
Fig. 2.
Graph comparing mean SNOT-22 scores before and after treatment
Table 2.
SNOT-22 scoring-intra-group comparison
| Before | After | p value | |||||||
|---|---|---|---|---|---|---|---|---|---|
| Mean | SD | Min | Max | Mean | SD | Min | Max | ||
| Control group | 38.90 | 12.01 | 21 | 57 | 25.70 | 9.21 | 12 | 43 | 0.0002 |
| Test group | 49.85 | 11.38 | 30 | 67 | 31.55 | 9.91 | 14 | 51 | < 0.0001 |
Compared to the pre-treatment scores, there was a significant decrease in the post-treatment LKES and SNOT-22 scores.
Discussion
CRS is defined as an inflammatory condition of the nasal cavity and paranasal sinuses that is considered to be the result of mucosal inflammation, which results in swelling and blockage at the sinus ostium. Due to mucus stasis caused by this, bacterial superinfection may follow. The aim of our study was to evaluate the efficacy of supplementing normal saline nasal spray to medical line of treatment for CRS.
Our findings showed that each patient had improved post-treatment to some extent in both the groups, more so in the test group. For control group, mean SNOT-22 score before the treatment was 38.90 ± 12.01 whereas after the treatment score was 25.70 ± 9.21 (p value was 0.0002). For test group, mean score before the treatment was 49.85 ± 11.38 whereas mean score after the treatment was 31.55 ± 9.91 (p value was < 0.0001).
The majority of symptom improvements were seen in patients with the highest symptom scores, highlighting the significance of the overall SNOT-22 score. This corresponds with a previous study by Smith TL et al., which has mentioned how those patients who were more seriously impacted showed greater improvement [7]. It’s crucial to note that improvements were seen even in the individuals with the lowest pre-operative symptom levels.
Objective confirmation of sino-nasal mucosal inflammation is necessary utilizing nasal endoscopy or diagnostic imaging due to clinical overlap with other frequent diseases. The most popular method for diagnosing medical issues affecting the nose and sinuses at the moment is nasal endoscopy which is a minimally invasive procedure. The LKES method was created in 1995 and is still the most widely used endoscopic scoring system [8]. Despite being created with postsurgical patients in mind, it is still often used to evaluate people who haven't had sinus surgery. According to our findings, all patients in both groups presented with some degree of improvement post-treatment, although a greater improvement was noted in the test group.
Nasal saline irrigation (NSI) is a helpful, low-risk therapy that aids in the treatment of CRS when used in conjunction with other methods like surgery and medicine. It is thought to work by thinning mucus, enhancing mucociliary clearance, reducing edema, and lessening the amount of antigens present in the nose and sinus cavities [9]. For these reasons, saline is beneficial in treating rhinitis, acute and chronic sinusitis, and other upper respiratory tract illnesses brought on by inflammatory mediators. Our study concludes that normal saline irrigation reduces symptoms of CRS. It also demonstrates high patient compliance with no reported side effects.
Studies show that in CRS or postoperative FESS patients, there is little advantage to utilizing hypertonic saline (HS) over isotonic saline (IS; 0.9%) [10]. Additionally, HS is linked to increased patient intolerance and discomfort [11]. When compared to dilute IS saltwater and regular water, an in-vitro investigation found that non-dilute IS seawater solution more efficiently increased ciliary beat frequency and wound repair speed [12]. In a different investigation, Woods et al. evaluated the effects of IS, HS, and low-salt solution on the antibacterial activity of nasal secretions and found that IS caused the antimicrobial activity to decline more significantly [13].
Conclusion
Normal Saline is a safe, locally used agent in the treatment of chronic rhinosinusitis. The patient tolerance is very good compared to hypertonic saline, Addition of Normal Saline to the standard medical treatment in chronic rhinosinusitis showed significant improvement in patient’s condition in our study. So, we conclude that use of Normal Saline should be considered in patients with chronic rhinosinusitis for its safety, tolerability and efficacy.
Author Contributions
All authors contributed to the study conception and design. Material preparation, data collection and analysis were performed by AJ. The first draft of manuscript was written by AJ. Review and guidance were provided by PHP and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.
Funding Statement
The authors did not receive support from any organization for the submitted work.
Declarations
Conflict of interest
The authors have no conflict of interests to declare.
Ethics Statement
The studies involving human participants were reviewed and approved by the institute.
Informed Consent
Informed consent was obtained from all individual participants included in the study.
Footnotes
Publisher's Note
Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
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